NIH’s response to the Institute of Medicine report addressing the use of chimpanzees in research

"NIH Director Dr. Francis Collins to provide NIH’s response to the Institute of Medicine report addressing the scientific need for the use of chimpanzees in research" NIH News Media Advisory 14 December 2011.

Could be interesting to contrast and compare regulatory officials stance on animal testing to that of experiments related to male circumcision.

The report is currently under embargo until Thursday, Dec. 15, 2011 at 11 a.m.

Who:

NIH Director Francis S. Collins, M.D., Ph.D.

When:

Thursday, Dec. 15, 2011, 12:30 p.m. EST

How:

Reporters should call: 800-619-4423 and enter passcode: 4490132.

For those unable to participate, the briefing will be available on replay approximately one hour after briefing concludes. For replay, dial: 800-685-1821.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. This involves planning, managing, and coordinating the programs and activities of all NIH components. The Office of the Director also includes program offices which are responsible for stimulating specific areas of research throughout NIH. Additional information is available at http://www.nih.gov/icd/od/

A long-awaited U.S. government-mandated report from the Institute of Medicine (IOM) recommends that the use of chimpanzees in biomedical research be conducted only in very limited circumstances.

The IOM, an independent body that is often charged with reviewing medical or scientific issues, has developed two sets of criteria to be used for deciding whether or not chimpanzees were necessary for biomedical research and for behavioral research.

The criteria included factors such as whether another suitable research model might be available, or whether the research could not be ethically performed in human subjects.

Based on this criteria, the panel concluded that the use of chimpanzees is not necessary for most medical research. One area where the committee felt chimpanzee research could possibly still provide a benefit in biomedical research was in monoclonal antibodies (a form of therapy used against cancer and other illnesses). The committee was spilt on whether such research might be necessary for the development of a preventive hepatitis C vaccine.

"When we applied the criteria to a number of disease areas and considered: 'Is there another model that could be used?' and 'Could this be done ethically in humans?' in many cases, the answer was yes," said committee member, Sharon Terry, president and CEO of Genetic Alliance in Washington D.C.

"The trajectory here is clear. While chimps were very useful in prior years, we will see a decline in their use in research," said Terry.

According to the Associated Press, the United States and the West African country of Gabon are the only two countries in the world known to conduct medical research with chimpanzees. The European Union banned this type of research in 2010. The use of chimpanzees for research in the United States has been on the decline, the AP said, with less than 1,000 animals now available in the country for medical research nationwide.

The use of animals in research has enabled scientists to identify new ways to treat illness, extend life, and improve health and well-being. Chimpanzees are our closest relatives in the animal kingdom, providing exceptional insights into human biology and the need for special consideration and respect. While used very selectively and in limited numbers for medical research, chimpanzees have served an important role in advancing human health in the past. However, new methods and technologies developed by the biomedical community have provided alternatives to the use of chimpanzees in several areas of research.

In December 2010, the National Institutes of Health commissioned a study by the Institute of Medicine to assess whether chimpanzees are or will be necessary for biomedical and behavioral research. The IOM now has issued its findings, with a primary recommendation that the use of chimpanzees in research be guided by a set of principles and criteria. The committee proposed three principles to analyze current and potential future research using chimpanzees.

1. That the knowledge gained must be necessary to advance the public’s health;
2. There must be no other research model by which the knowledge could be obtained, and the research cannot be ethically performed on human subjects; and
3. The animals used in the proposed research must be maintained either in ethologically appropriate physical and social environments (i.e., as would occur in their natural environment) or in natural habitats.

Based on its deliberations, the IOM committee concluded that “while the chimpanzee has been a valuable animal model in past research, most current use of chimpanzees for biomedical research is unnecessary.” The committee also concluded, however, that the following areas may continue to require the use of chimpanzees: some ongoing research on monoclonal antibody therapies, research on comparative genomics, and non-invasive studies of social and behavioral factors that affect the development, prevention, or treatment of disease. The committee was unable to reach consensus on the necessity of the chimpanzee for the development of prophylactic hepatitis C virus vaccine. While the committee encouraged NIH to continue development of non-chimpanzee models and technologies, it acknowledged that new, emerging, or re-emerging diseases may present challenges that may require the use of chimpanzees.

I have considered the report carefully and have decided to accept the IOM committee recommendations. NIH is in the process of developing a complete plan for implementation of the IOM’s guiding principles and criteria. I will be assembling a working group within the NIH Council of Councils to provide advice on the implementation of the recommendations, and to consider the size and placement of the active and inactive populations of NIH-owned or -supported chimpanzees. We will not issue any new awards for research involving chimpanzees until processes for implementing the recommendations are in place.

NIH is committed to conducting and supporting high-quality science in the interest of advancing public health, and to the humane care and use of animals used in NIH research. I am grateful to the IOM for their careful and thoughtful assessment of this important and sensitive topic.

Ongoing projects and applications submitted before NIH's announcement may proceed for now. An NIH working group will reassess the research on a project-by-project basis to determine if it meets the IOM's criteria. If not, the research will be phased out.

The National Institutes of Health, after extensive collaboration with the Chimp Haven federal sanctuary, New Iberia Research Center (NIRC), and other organizations, has developed a plan to formally retire directly to the Federal Sanctuary System all of its chimpanzees at New Iberia that were recently designated as permanently ineligible for biomedical research. The NIH animals housed at NIRC, New Iberia, La., are to be transferred to the Chimp Haven sanctuary in Keithville, La., over the next 12-15 months.

"These animals have made important contributions to research to improve human health, but new technologies have reduced the need for their continued use in research," said NIH Director Francis S. Collins, M.D., Ph.D. "We are grateful to all of the organizations that have pulled together to help us transition these animals into formal retirement."